Page:United States Statutes at Large Volume 121.djvu/940

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[121 STAT. 919]
[121 STAT. 919]
PUBLIC LAW 110-000—MMMM. DD, 2007

PUBLIC LAW 110–85—SEPT. 27, 2007

121 STAT. 919

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‘‘(I) requiring clinical trial information with respect to an applicable clinical trial to include information from any source other than such clinical trial involved; or ‘‘(II) requiring clinical trial information described in paragraph (3)(D) to be submitted for purposes of paragraph (3)(C). ‘‘(E) PUBLIC NOTICES.— ‘‘(i) NOTICE OF VIOLATIONS.—If the responsible party for an applicable clinical trial fails to submit clinical trial information for such clinical trial as required under paragraphs (2) or (3), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice— ‘‘(I) that the responsible party is not in compliance with this Act by— ‘‘(aa) failing to submit required clinical trial information; or ‘‘(bb) submitting false or misleading clinical trial information; ‘‘(II) of the penalties imposed for the violation, if any; and ‘‘(III) whether the responsible party has corrected the clinical trial information in the registry and results data bank. ‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND SECONDARY OUTCOMES.—If the responsible party for an applicable clinical trial fails to submit the primary and secondary outcomes as required under section 2(A)(ii)(I)(ll), the Director of NIH shall include in the registry and results data bank entry for such clinical trial a notice that the responsible party is not in compliance by failing to register the primary and secondary outcomes in accordance with this act, and that the primary and secondary outcomes were not publicly disclosed in the database before conducting the clinical trial. ‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice under clause (i) for a violation described in clause (i)(I)(aa) shall include the following statement: ‘The entry for this clinical trial was not complete at the time of submission, as required by law. This may or may not have any bearing on the accuracy of the information in the entry.’. ‘‘(iv) SUBMISSION OF FALSE INFORMATION STATEMENT.—The notice under clause (i) for a violation described in clause (i)(I)(bb) shall include the following statement: ‘The entry for this clinical trial was found to be false or misleading and therefore not in compliance with the law.’. ‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice under clause (ii) for a violation described in clause (ii) shall include the following statement: ‘The entry for this clinical trial did not contain information on the primary and secondary outcomes at the time of submission, as required by law. This may or may not

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